510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171257Substantially Equivalent

ClearPoint System

Mri Interventions, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171257 is the FDA 510(k) clearance record for ClearPoint System, a class II device, cleared for Mri Interventions, Inc. on under FDA product code ORR (Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri). FDA's definition for product code ORR reads: "To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite". FDA records list 14 510(k) clearances for Mri Interventions, Inc., from to . As of , FDA records show no recalls naming K171257.

Clearance record

Decision date
Received
(175 days to decision)
Product code
ORR Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Mri Interventions, Inc. 5 Musick, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORR

Trailing 12 months

FDA records hold no clearances under product code ORR in the trailing twelve months.

FDA records show no clearances under product code ORR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ORR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260